Career Category
Quality
Job Description
Role summary
Amgen China Quality Manager
安进中国质量经理
The International & Distribution Quality (IDQ) team supports products to and in the market after our manufacturing sites have produced high-quality medicines for our patients. The China IDQ team is a commercial-facing group that has oversight over finished drug product distribution in China. This oversight includes business partners, Logistics service providers, distributors, wholesalers, contract packaging, import testing laboratories product complaints, and Affiliate QMS to ensure our products are safe and effective.
中国国际与分销质量（IDQ）负责支持产品进入中国市场并在市场上流通。中国IDQ团队是一个面向商业的团队，负责监督在中国的成品药品分销。这项监督工作包括业务合作伙伴、物流服务提供商、分销商、批发商、合同包装、进口测试实验室、产品投诉以及附属质量管理系统（QMS），以确保产品安全有效。
The Manager Quality Assurance is responsible for leading and conducting the following Quality Assurance activities to support China GSP/GMP requirements as well as JAPAC regional activities where required.
质量保证经理负责领导和执行以下质量保证活动，以支持中国GSP/GMP要求以及在需要时支持JAPAC区域活动。
Job Description
Responsibilities include, but not limited to:
职责包括但不限于：
- To ensure quality oversight of product supply and commercial operations in China within the requirements of the Amgen QMS and the Chinese GSP /GMP regulatory requirements
确保在中国的产品供应和商业运营符合安进质量管理体系（QMS）和中国GSP/GMP法规要求。
- Perform in-country disposition for imported products and status changes as required.
根据需要，进行进口产品的国内处置和状态变更。
- Perform an assessment and/or approval of non-conformances/deviations and including temperature excursions; report to management on trends. 评估和/或批准不合格/偏差，包括温度偏差，并向管理层报告趋势。
- Interface with partners and collaboration companies in China.
作为中国的合作伙伴和合作公司的对接人。
- Support of the region's programs and processes.
支持区域项目和流程。
- Project lead or team member for China Quality Systems and may act as interface to quality/operations, customers, and other global project lead as required.
担任中国质量体系的项目负责人或团队成员，并在需要时作为质量/运营、客户和其他全球项目负责人的对接人。
- Lead the development and strategy for the distribution quality oversight and requirements
领导分销质量监督和要求的发展和策略。
- Participate and provide quality support on the working teams for new product launches
参与并在新产品引入项目中提供质量支持。
- Write/review/approve local and global documentation in accordance with relevant regulatory requirements and Amgen policy ensuring specifically that China GSP /GMP requirements are included.
根据相关法规要求和安进政策，编写/审核/批准本地和全球文件，确保包括中国GSP/GMP要求。
- Represent China in Regional Management Review as SME.
作为主题专家（SME）代表中国参加区域管理评审。
- Write / Review supplier technical agreements or quality agreements which include Provide quality assessments for change control, risk management plans, transport lanes, temperature monitoring plans, periodic evaluations and management plans.
编写/审核供应商技术协议或质量协议，包括提供变更控制、风险管理计划、运输路线、温度监控计划、定期评估和管理计划的质量评估。
- Provide oversight of product complaints by ensuring all quality complaints are documented, evaluated, investigated within company policy and regulatory timeframe expectations.
对质量投诉进行监督，确保所有的质量投诉均在公司政策和法规要求时间内完成记录、评估、调查。
- Generate product complaint monitoring reports and reports to management and commercial on trends.
生成产品投诉监督报告，并向管理层和商业部门报告趋势。
- Provide quality guidance for commercial programs including patient support programs and Product Complaint training
为商业项目提供质量指导，包括患者支持项目和产品投诉培训。
- Participate in regulatory inspection of Amgen manufacturing facilities as needed.
根据需要参与安进生产工厂的法规检查。
- Perform self-assessments of GMP/GSP processes.
执行GMP/GSP流程的自我评估。
- Perform Supplier Security Audit for Amgen internal customers
为安进内部客户执行供应商安全审计。
- General project and system support for JAPAC IDQ
为日本及亚太区国际及分销质量提供项目和系统支持。
Basic Qualifications
- Master’s degree and 6 years of Pharmacy, medicine, biology, chemistry and other related majors and Quality or Operations experience OR Bachelor’s degree or and 8 years of Quality or Operations experience
- ,且硕士学位和6年及以上的质量或运营经验，或者学士学位和8年及以上的质量或运营经验。
- Chinese Language fluency
- English language fluency
Preferred Qualifications
- 8+ years of quality assurance or combination of quality manufacturing, and distribution experience in the biotechnology/pharmaceutical industry
- /制药行业拥有8年以上的质量保证或质量生产和分销经验。
- Experience studying or working outside of China
- Knowledge in manufacturing, investigations, CAPA, product release, validation and/or change control
- CAPA）、产品放行、验证和/或变更控制方面的知识。
- Lead and practice in QMS establishment according to China GSP/GMP and related regulations, standards and guidelines that apply to biotech manufacturing.
- GSP/GMP及相关法规、标准和指南，领导和实践质量管理体系（QMS）的建立。
- Ability to achieve established timelines and deliver results to meet or exceed department and company goals and objectives
- Excellent communication skills both written and verbal; facilitate discussions and present to audiences at all levels of a site organization
- Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing
- Demonstrated ability to work as both a team player and independently
Competencies:
- Established Leadership capabilities
- Passion for Operational Excellence
- Communications skills, both oral and written, including executive presentation skills
- Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
- Ability to tactfully negotiate and positively influence peers and executive leadership
- Analytical skills to identify potential improvement opportunities
- Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)
- Strong collaborative working relationships with all stakeholders including local Commercial and local/global Operations stakeholders.
- /全球运营利益相关者）建立强有力的协作工作关系。
- Continued product supply to patients through on time disposition and completion of quality activities relating to supply.
- /完成与供应相关的质量活动，确保持续向患者供应产品。
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